Pharmaceutical and in vitro therapeutic equivalence studies of ketoprofen enteric coated 100 mg tablets

The objective of this study was to assess the quality of six different brands of enteric coated Ketoprofen 100 mg tablets, KPB to KPB6 are available in commercial market of Karachi, Pakistan, while KPB1 was obtained from international source. We performed different physico-chemical assessments i.e....

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Bibliographic Details
Published in:Pakistan journal of pharmaceutical sciences 2017-01, Vol.30 (1), p.179-186
Main Authors: Zafar, Farya, Shoaib, Muhammad Harris, Ali, Huma, Yousuf, Rabia Ismail, Naqvi, Ghazala Raza, Nisa, Zebun, Shafiq, Yusra
Format: Article
Language:English
Subjects:
Anti-Inflammatory Agents, Non-Steroidal - chemistry
Anti-Inflammatory Agents, Non-Steroidal - standards
Assaying
Drug Compounding
Hardness
Hardness Tests
Hydrogen-Ion Concentration
Ketoprofen
Ketoprofen - chemistry
Ketoprofen - standards
Kinetics
Models, Chemical
Pakistan
Quality Control
Solubility
Tablets, Enteric-Coated
Technology, Pharmaceutical - methods
Therapeutic Equivalency
Weibull distribution
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Summary:The objective of this study was to assess the quality of six different brands of enteric coated Ketoprofen 100 mg tablets, KPB to KPB6 are available in commercial market of Karachi, Pakistan, while KPB1 was obtained from international source. We performed different physico-chemical assessments i.e. weight variation, diameter, hardness, friability, thickness, disintegration, content uniformity, assay and dissolution test. Results of all the investigations were found to be in adequate limits. Also pharmaceutical equivalence was determined by selecting different tests and assay assessment. Furthermore, in vitro therapeutic equivalence was also estimated at phosphate buffer pH 6.8 and 7.5. Results were evaluated by one way ANOVA, model independent and model dependent methods. ANOVA results showed that release behaviour were found to be similar as p values >0.05, also KPB - KPB followed Weibull model at different dissolution media. Results indicated that innovator and brands not only passes the pharmaceutical equivalence assessment but also comply with the in vitro therapeutic equivalence.
ISSN:1011-601X